Back to search results

Celiac Disease Genomic Environmental Microbiome and Metabolomic Study (CDGEMM)

This observational study, called CDGEMM, is looking at how genes, environment, gut bacteria (microbiome), and body chemistry (metabolomics) might lead to celiac disease (CD). You can participate if you are a newborn or infant under 6 months old, have not started solid foods, and have a close family member (first-degree relative) with celiac disease. The study aims to understand what factors increase the risk of developing CD by following infants over time. Researchers will look at changes in gut bacteria composition every six months until age five, especially around when gluten is introduced and if autoimmunity develops. The goal is to find ways to prevent or detect CD early in children at high risk.

Study design
This is an observational study planning to enroll 500 participants. It is not testing a specific intervention or drug.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed every six months through five years of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02061306

Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

Recruiting
Not specifiedUp to 6Observational
Massachusetts General Hospital
~500 participants
Updated 2026-04-17 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in composition of the microbiota of CD in at-risk infants using culture-independent high-throughput sequence analysis of the 16S rRNA genes using the Illumina sequencing platform.
Measured over Every six months through five years of age with specific focus on time of gluten introduction, time at which gluten tolerance is lost and autoimmunity develops (if applicable), and parallel time points in infants who do not go on to develop autoimmunity

Conditions

Celiac Disease

Explore related trials

Celiac Disease

NCT02061306

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MassGeneral Hospital for Children

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • University of Roma La Sapienza

    Rome, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alessio Fasano, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • Maureen M. Leonard, MD · STUDY_CHAIR · Massachusetts General Hospital

Who to contact

Victoria Kenyon, MHA
[email protected]
617-643-4366
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Newborns and infants less than 6 months of age who have not been introduced to solid foods (exclusive breast milk or formula diet)
First-degree relatives of patients affected with biopsy-proven CD

Exclusion

Infants older than 6 months of age
Inability or unwillingness of legal guardian/representative to give written informed consent

What this trial measures

  • Change in composition of the microbiota of CD in at-risk infants using culture-independent high-throughput sequence analysis of the 16S rRNA genes using the Illumina sequencing platform.Every six months through five years of age with specific focus on time of gluten introduction, time at which gluten tolerance is lost and autoimmunity develops (if applicable), and parallel time points in infants who do not go on to develop autoimmunity

    We will use stool samples collected over time to survey the microbial community in order to establish microbiota patterns associated with CD autoimmunity.